Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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Impact of Ambulatory Oxygen Delivery on Real-world Activity and Quality-of-life in Patients With Interstitial Lung Disease (ILD) and Chronic Obstructive Pulmonary Disease (COPD)

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Fibrotic forms of interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD) are chronic lung disease which often affect how well oxygen can get from the lungs into the blood. Low blood oxygen levels often leads to shortness of breath which can affect patients' activity levels and quality-of-life. Many people with fibrotic ILD and COPD only have low oxygen levels when they are walking or exercising. Oxygen that is only used for walking or exercise is called ambulatory oxygen therapy (AOT). Laboratory studies suggest that AOT improves shortness of breath and exercise ability. However, real-world studies of AOT have not shown similar results. AOT can be given to patients through different types of equipment, most commonly oxygen tanks or portable oxygen concentrators (POCs). While previous studies have suggested that AOT does not significantly improve patients' breathing or activity in the real-world, these studies most often gave all participants the same amount of oxygen with the same device. However, patients with ILD and COPD often have very different oxygen needs during exercise, and POCs and oxygen tanks are very different in how oxygen is administered. This trial will test the feasibility of a study to determine whether real-world activity, symptoms, and quality-of-life are different with the use of different oxygen equipment when oxygen therapy has been adjusted to meet each participants' oxygen needs. A total of 24 participants (12 with fibrotic ILD and 12 with COPD) who only have low oxygen levels with activity will be randomly assigned to 2-week periods using either no oxygen therapy or oxygen delivered by oxygen tanks or POC. This trial will provide preliminary data to support a larger clinical trial to further test how different AOT equipment titrated to meet individual patients' needs may affect real-world outcomes in people with ILD and COPD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Adults \>= 18 years old and \<= 85 years old with fibrotic ILD or COPD able to provide informed consent

• Fibrotic ILD includes idiopathic pulmonary fibrosis, sarcoidosis, or other ILD with fibrotic changes on lung imaging (reticulations, honeycombing, traction bronchiectasis)

• COPD participants will have fixed airway obstruction on spirometry less than 70%-predicted as per Global Initiative for Obstructive Lung Disease (GOLD) diagnostic criteria

• Participants will self-report as being ambulatory outside of home without use of assistance device such as a cane or walker

• Stable lung disease on stable medical therapy for preceding 3 months

• Isolated exertional hypoxemia (SpO2 less than 89% for \>=10 seconds) on a 6MWT conducted while breathing room air

• Able to maintain SpO2 \>=89% for the full duration of a 6MWT while using the the POC and portable oxygen D-tank at POC setting of no higher than 6 and D-tank flow rate no higher than 6 liters per minute

Locations
United States
New York
State University of New York at Buffalo Jacobs School of Medicine and Biomedical Sciences
RECRUITING
Buffalo
Contact Information
Primary
Kristopher Clark, MD
kclark4@buffalo.edu
7168591516
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2027-10
Participants
Target number of participants: 24
Treatments
Active_comparator: Fibrotic Interstitial Lung Disease
Participants with a pulmonologist-diagnosed fibrotic interstitial lung disease (idiopathic pulmonary fibrosis or other interstitial lung disease with fibrotic changes on chest imaging) who are ambulatory outside of home and who demonstrate isolated exertional hypoxemia on a 6-minute walk test.
Active_comparator: Chronic obstructive pulmonary disease
Participants with chronic obstructive pulmonary disease (COPD) with fixed airway obstruction less than 70% predicted who are ambulatory outside of the home and who demonstrate isolated exertional hypoxemia on a 6-minute walk test.
Sponsors
Leads: State University of New York at Buffalo
Collaborators: National Center for Advancing Translational Sciences (NCATS)

This content was sourced from clinicaltrials.gov